Injection device with cammed ram assembly

ABSTRACT

An exemplary embodiment of injector includes a trigger mechanism, an energy source, and a user-operable firing-initiation member. The trigger member can include a trigger member having a retainer portion, and a ram assembly having a ram configured to pressurize a medicament container for expelling a medicament therefrom and a trigger engagement member configured to engage the retainer portion of the trigger member in a pre-firing condition. The energy source can be associated with the ram for powering the ram to expel the medicament, and the user-operable firing-initiation member can be operable for causing an axial rotation between the trigger engagement member and the retainer portion from the pre-firing condition to a firing condition in which the trigger engagement member is released from the retainer portion to allow the energy source to fire the ram.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims benefit from U.S. Provisional Patent ApplicationNo. 61/643,659, filed 7 May 2012, U.S. Provisional Patent ApplicationNo. 61/643,845, filed 7 May 2012, U.S. Provisional Patent ApplicationNo. 61/776,283, filed 11 Mar. 2013, and U.S. Provisional PatentApplication No. 61/763,395, filed 11 Feb. 2013, each of which isincorporated herein by reference in its entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates to injection devices, and in particularto a needle assisted jet injector.

BACKGROUND INFORMATION

Various injection devices exist that employ an automated mechanism toactuate injection of a liquid medicament into a patient. Examples ofsuch devices include jet injectors (both needle-free andneedle-assisted) and traditional, low-pressure auto-injectors (thatprovide, for example, mechanized delivery of a traditional,finger-powered hypodermic syringe injection). Although the precisemechanisms used to complete an injection can vary, most include afeature that stores kinetic energy that can be used to drive aninjection mechanism during use. Further, many injectors include atrigger mechanism configured to ensure that the kinetic energy remainsstored until an injection is desired, whereby actuation of the triggerreleases the injection mechanism, allowing the stored kinetic energy todrive the injection mechanism to cause injection.

Examples of needle-free jet injectors are described, for example, inU.S. Pat. Nos. 5,599,302; 5,062,830; and 4,790,824. These injectorsadminister medication as a fine, high velocity jet delivered undersufficient pressure to enable the jet to pass through the skin. Theinjection mechanism in such needle-free jet injectors can apply a forceto a medicament storing chamber within the device such that the pressurerequired to inject the medicament is created within the chamber.

Traditional self-injectors or auto-injectors like the ones described,for example, in U.S. Pat. Nos. 4,553,962 and 4,378,015 and PCTPublications WO/9929720 and WO/9714455 inject medicament at a rate andin a manner similar to hand-operated hypodermic syringes. The describedself-injectors or auto-injectors have needles that are extended at thetime of activation to penetrate the user's skin to deliver medicamentthrough movement of the drug container and related needle. Thus, themechanism that provides the force to deliver the medicament intraditional, low-pressure self-injectors and auto-injectors can also beused to extend the needle and displace the drug container to cause theinsertion of the needle through the user's skin and to apply a force toa plunger movably disposed within the drug container to cause themedicament to be expelled from the container through the needle. Theauto-injectors manufactured, for example by Owen Mumford, thus use verylow pressures to inject the medicament, which is typically injectedthrough a needle in a relatively slow stream. Another self-injectorincludes the Simponi injector, which includes a window in the housingthrough which a yellow ram is visible inside a clear medicamentcontainer once the injector has been used.

Additionally, needle-assisted jet injectors have also been developedthat utilize a needle to initially penetrate the skin, to the higherinjection forces allowing but not restricted to an insertion depth lessthan that of a traditional hypodermic injector or low-pressureauto-injectors. Once the skin is penetrated with the needle, a jetmechanism is activated, causing the medicament containing liquid withinthe injector to be pressurized and expelled through the needle and intothe skin. The injection mechanism in needle-assisted jet injectors canbe configured to move the drug container and the needle forward topenetrate the skin and exert the necessary injection force to a plungermoveably disposed within the container. Alternatively, the needle anddrug container can be positioned to penetrate the skin while keeping theneedle and drug container in a stationary position, and the injectionmechanism can be structured to pressurize the container. The pressureapplied to the medicament within the injector can be less than that of atraditional jet injector, because the outer layers of the skin havealready been penetrated by the needle. Similarly, the pressure appliedto the medicament is preferably higher than that of a traditionalauto-injector or the like, causing the medicament to penetrate the skinor the tissue below the skin to a depth that is sufficient so that themedicament remains substantially within the body. An additional benefitof the higher pressure includes a faster time of injection resulting inless psychological trauma to the patient and a decreased likelihood ofthe user inadvertently terminating the injection prematurely by removingthe injector from the injection site.

Because of the stored energy associated with the trigger and injectionmechanisms, accidental firing can occur due to sudden movements duringshipping or due to mishandling of the device by a user includingaccidental actuation of the trigger mechanism. Accidental firing of theinjection mechanism can cause the medicament to be expelled from thedevice, which can be at a dangerously high pressure, depending on thetype of injection device. Further, accidental firing can cause aninjection needle to move forward with respect to the device withsufficient force to penetrate the skin.

Additionally, the dimensions of many components incorporated ininjectors typically constrain the design of many injectors. For example,many injectors utilize front triggering mechanisms that typicallyrequire an axial translation and engagement with a triggering structurelocated at the back of the injector. However, this configurationtypically prevents binding of the communicating triggering components,which can be advantageous for, e.g., reducing the size of the injectiondevice, being able to view the drug container within the device, etc.

SUMMARY

Exemplary embodiments of the present disclosure are directed toinjection devices. An exemplary embodiment of the present disclosure canprovide an injector including a trigger mechanism, an energy source, anda user-operable firing-initiation member. The trigger member can includea trigger member having a retainer portion, and a ram assembly having aram configured to pressurize a medicament container for expelling amedicament therefrom and a trigger engagement member configured toengage the retainer portion of the trigger member in a pre-firingcondition. The energy source can be associated with the ram for poweringthe ram to expel the medicament, and the user-operable firing-initiationmember can be operable for causing an axial rotation between the triggerengagement member and the retainer portion from the pre-firing conditionto a firing condition in which the trigger engagement member is releasedfrom the retainer portion to allow the energy source to fire the ram.The exemplary injector can further include an injection housing, wherethe trigger engagement member and the ram are in fixed association, suchthat rotation of the trigger engagement member rotates the ram, and theram assembly is associated with the firing-initiation member such thatoperation of the firing-initiation member rotates the ram assemblywithin the housing to the firing condition.

The exemplary injector can further include an injector housing. Thefiring initiation member can also include a skin-contacting memberdisposed at a distal end of the injector that is movable proximally withrespect to the housing when a force is applied to the skin-contactingmember at the distal end of the injector. Further, the firing initiationmember can be associated with the trigger mechanism and configured tocause the axial rotation between the trigger engagement member and theretainer portion from the pre-firing condition to the firing conditionupon a proximal movement of the skin-contacting member with respect tohousing. Additionally, the skin-contacting member can include a needleguard that is retractable and is configured to expose a needle connectedto the medicament container upon the proximal movement of theskin-contacting member.

According to another exemplary embodiment of the present disclosure, theneedle can be in fluid communication with the medicament container forinjecting the medicament expelled therefrom during the firing. Further,the energy source and the needle can be configured for jet injecting themedicament through the needle. The energy source can be configured topressurize the medicament to between about 90 p.s.i. and about 500p.s.i. to jet inject the medicament, and the energy source and needlecan be configured for injecting the medicament at an average velocity ofat least about 1,000 cm/sec within the needle.

According to another exemplary embodiment of the present disclosure, theskin contacting member can include a first cam, and the ram assembly caninclude a second cam. The first cam can be operatively associated withthe second cam for camming the second cam upon the axial movement torotate the ram assembly with respect to the retainer portion so as toposition the ram assembly in the firing condition. The trigger mechanismcan include a ram holding member that axially retains the ram assemblyin a proximal position against action of the energy source in thepre-firing position, the retainer portion retaining the triggerengagement member engaged and held against firing by the ram holdingmember. Additionally, in the firing condition, the ram can be disengagedfrom the retainer portion, and the energy source overcomes an engagementbetween the trigger engagement member and the ram holding member.Further, the ram holding member can include a projection that includes abulge and a groove engaged with the trigger engagement member, and theretainer portion retaining said engagement of the trigger engagementmember with the bulge and groove, in the pre-firing condition.

According to certain exemplary embodiments of the present disclosure,the ram assembly can be of unitary construction.

According to yet another exemplary embodiment of the present disclosure,the injector can further include a container support that is configuredfor holding the medicament container during injection, and wherein theram assembly is configured to engage the container support to lock-outthe injector after an injection. Further, proximal movement of theuser-operable firing-initiation member can be blocked by the ramassembly when the injector is locked-out.

According to yet another exemplary embodiment of the present disclosure,a pre-firing color gamut is visible from the exterior of the injector inthe pre-firing condition. Further, the injector can further include ahousing including a window; and an indicator having an indicator colorthat is absent from the pre-firing color gamut, which color is hiddenfrom view within the housing in the pre-fired condition, and in thefired condition, the indicator color is visible through the window fromthe exterior of the injector for indicating the fired condition. Incertain embodiments, the ram assembly can include the indicator, and theram assembly can entirely occlude the window in the fired condition.

Yet another exemplary embodiment of the present disclosure can providean injector including a trigger mechanism having a trigger member havinga retainer portion, and a ram assembly having a ram configured topressurize a medicament container for expelling a medicament therefromand at least one first camming surface. The ram assembly can furtherinclude a trigger engagement member configured to engage the retainerportion of the trigger member in a pre-firing condition. The injectorcan further include an energy source associated with the ram forpowering the ram to expel the medicament, and a needle guard including auser-operable firing-initiation member operable having at least onesecond camming surface configured to operatively associate with the atleast one first camming surface so as to cause an axial rotation betweenthe trigger engagement member and the retainer portion from thepre-firing condition to a firing condition in which the triggerengagement member is released from the retainer portion to allow theenergy source to fire the ram. The injector can further include acontainer support, and the ram assembly can be configured to engage thecontainer support to lock-out the injector after an injection.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects, features and advantages of the invention willbe apparent from a consideration of the following non-limiting detaileddescription considered in conjunction with the drawing figures, inwhich:

FIG. 1A is a side partial cross-sectional view of an exemplary injectiondevice according to an exemplary embodiment of the present disclosure;

FIG. 1B is a cross-sectional view of an exemplary injection deviceaccording to an exemplary embodiment of the present disclosure;

FIG. 1C is a side view of a housing of an exemplary injection deviceaccording to an exemplary embodiment of the present disclosure;

FIG. 2A is a perspective view of a proximal portion of an exemplaryinjection device according to an exemplary embodiment of the presentdisclosure;

FIG. 2B is another perspective view of a proximal portion of anexemplary injection device according to an exemplary embodiment of thepresent disclosure;

FIG. 3 is a side view of an end housing portion of an exemplaryinjection device according to an exemplary embodiment of the presentdisclosure;

FIGS. 4A and 4B are side and perspective views respectively of a fronthousing portion and a sleeve of an exemplary injection device accordingto an exemplary embodiment of the present disclosure;

FIGS. 5A and 5B are side and perspective views respectively of a needleguard of an exemplary injection device according to an exemplaryembodiment of the present disclosure;

FIGS. 6A and 6B are side and perspective views respectively of a ramassembly of an exemplary injection device according to an exemplaryembodiment of the present disclosure;

FIG. 7 is an exploded view of an exemplary injection device according toan exemplary embodiment of the present disclosure;

FIGS. 8A-13C are side, cross-sectional, and internal views of anoperation of an exemplary injection device according to an exemplaryembodiment of the present disclosure;

FIG. 14 shows a cross sectional view of a cap of an exemplary injectiondevice according to an exemplary embodiment of the present disclosure;

FIG. 15 shows a close-up view of an engagement of a trigger engagementmember and a ram retaining member of an exemplary injection deviceaccording to an exemplary embodiment of the present disclosure;

FIG. 16 shows a side view of an exemplary injection device according toan exemplary embodiment of the present disclosure;

FIG. 17 shows a top view of a ram assembly of an exemplary injectiondevice according to an exemplary embodiment of the present disclosure;and

FIG. 18 shows a partially cut-away perspective view of a proximalportion of an exemplary injection device according to another embodimentof the present disclosure.

Throughout the drawings, the same reference numerals and characters,unless otherwise stated, are used to denote like features, elements,components, or portions of the illustrated embodiments. Moreover, whilethe present disclosure will now be described in detail with reference tothe figures, it is done so in connection with the illustrativeembodiments and is not limited by the particular embodiments illustratedin the figures.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

FIG. 1A shows an exemplary injection device 100 according to anexemplary embodiment of the present disclosure. It is noted that, in thecontext of this disclosure, the terms “distal” and “proximal” are usedin reference to the position of the injection device relative to a userof the injection device when merely held by a user. Accordingly, a pointlocated distal to a second point would be further from the user (i.e.,towards an injection end of the injection device) and vice versa. Asshown in the drawings, the exemplary injection device 100 is preferablya needle assisted jet injection device, although a person havingordinary skill in the art will understand alternative embodimentsemploying certain features herein can be configured as needle-free jetinjectors, or as low-pressure auto-injectors or other mechanizedinjectors. According to certain exemplary embodiments, injection device100 can be a one-time disposable needle-assisted jet injector with alock-out feature. For example, injection device 100 can facilitate a jetinjection of medicament stored within injection device 100 and caninclude a locking feature that prevents a user from attempting to useinjection device 100 once the medicament has been dispensed. Preferably,the locking feature is activated upon dispensing of the medicament andnot upon use of injection device 100. For example, the locking featurecan be activated, thus preventing injection device 100 from a subsequentattempted use by a user, even in the case where the injection device wasnot used by a user for an injection, but where a firing mechanism wasinadvertently activated (e.g., during transport, handling, etc. of thedevice) and the medicament was dispensed. Operation of injection device100, including the locking feature, is described in further detailbelow.

According to certain exemplary embodiments, injection device 100 candeliver any suitable liquid drug or medicament. Further, injectiondevice 100 can allow the injection to be administered by individualsthat do not have formal training (e.g., self-administered oradministered by another individual family member or other caregiver whomay not be a formally trained healthcare provider, such as a parentadministering a drug to a child). Accordingly, injection device 100 canbe useful in situations where self-injections/caregiver administeredinjections would be beneficial, including, but not limited to, low T,hypogonadism, diabetes, infertility treatment, sexual dysfunction,cardiovascular disease, oncology supportive care, allergic reaction,multiple sclerosis, rheumatoid arthritis psoriasis, other autoimmuneconditions including Crohn's disease and SLE, chronic pain, migraine,epileptic seizure, kidney disease, and the like. Further, injectiondevice 100 can be used to inject a wide range of drugs. For example,injection device 100 can be used to inject drugs, water solublemedicaments and oil soluble medicaments. In one embodiment, themedicament includes a benzodiazepine, including midazolam. In anotherembodiment, the medicament is dissolved in oil instead of aqueoussolutions, and can include hormone drugs used in men (e.g.,testosterone, or a derivative or ester thereof) and women; smallmolecule injectable drugs such as, methotrexate (see, e.g.,International Publication No. WO 2010/108116, which is incorporated byreference herein in its entirety); and/or biological drugs, includingthose having a high viscosity. Further, and as noted above, injectiondevice 100 can be used to inject androgens, including testosteroneformulations (e.g., testosterone cypionate and testosterone enanthate).

Testosterone is a steroid hormone from the androgen group. In general,androgens promote protein synthesis and growth of those tissues withandrogen receptors. Testosterone is anabolic, meaning it builds up boneand muscle mass. Testosterone has the following structural formula:

The original and primary use of testosterone is for the treatment ofmales who have too little or no natural endogenous testosteroneproduction—males with Low T or hypogonadism. According to theMassachusetts Male Aging Study, about 6% to 12% men aged 40 to 60 yearshave symptomatic low testosterone deficiency. However, over the years,testosterone has also been given for many other conditions, e.g.,reducing infertility, correcting lack of libido or erectile dysfunction,correcting osteoporosis, encouraging penile enlargement, encouragingheight growth, encouraging bone marrow stimulation, reversing theeffects of anemia and appetite stimulation.

In certain embodiments, injection device 100 can be used to inject oneor more of epinephrine, atropine, dihydroergotamine, sumatriptan,antibiotics, antidepressants, anticoagulants, glucagon, diazepam,haloperidol, apomorphine, lovenox, and toradol. In other embodiments,injection device 100 can be used to inject biosimilar, biological and orpeptide drugs, including without limitation Enbrel, Humira, Lantus,Epogen (Procrit), Neulasta, Aranesp, Avonex, PEGasys, Rebif, Neupogen,Betaseron, Avastin, Remicade, Herceptin, Erbitux, Recombinate, Cerezyme,NovoSeven, Tysabri, Synagis, Copaxone and Kogenate FS.

In other embodiments, injection device 100 can be used to injectparathyroid hormone (“PTH”) and various other medications such asexenatide and the like. Injection device 100 can also be used to injectmedicaments listed in the Physicians' Desk Reference (PDR®), 67thEdition (2013) (which is herein incorporated by reference in itsentirety), and, without limitation, allergens, amebicides andtrichomonacides, amino acid preparations, analeptic agents, analgesics,analgesics/antacids, anesthetics, anorexics, antacids, antihelmintics,antialcohol preparations, antiarthritics, antiasthma agents,antibacterials and antiseptics, antiviral antibiotics, anticancerpreparations, anticholinergic drug inhibitors, anticoagulants,anticonvulsants, antidiabetic agents, antidiarrheals, antidiuretics,antienuresis agents, antifibrinolytic agents, antifibrotics (systemic),antiflatulents, antifungal agents, antigonadotropin, antihistamines,antihyperammonia agents, anti-inflammatory agents, antimalarials,antimetabolites, antimigraine preparations, antinauseants,antineoplastics, anti-obesity preparations, antiparasitics,anti-parkinsonism drugs, antipruritics, antipyretics, antispasmodics andantichloinergics, antitoxoplasmosis agents, antitussives, antivertigoagents, antiviral agents, biologicals, biosimilars, bismuthpreparations, bone metabolism regulators, bowel evacuants, bronchialdilators, calcium preparations, cardiovascular preparations, centralnervous system stimulants, cerumenolytics, chelating agents,choleretics, cholesterol reducers and anti-hyperlipemics, coloniccontent acidifiers, cough and cold preparations, decongestants,diazepam, epinephrine expectorants and combinations, diuretics, emetics,enzymes and digestants, fertility agents, fluorine preparations,galactokinetic agents, general anesthetic, geriatrics, germicides,hematinics, hemorrhoidal preparations, histamine H receptor antagonists,hormones, hydrocholeretics, hyperglycemic agents, hypnotics,immunosuppressives, laxatives, mucolytics, muscle relaxants, narcoticantagonists, narcotic detoxification agents, ophthalmological osmoticdehydrating agents, otic preparations, oxytocics, parashypatholytics,parathyroid preparations, pediculicides, phosphorus preparations,premenstrual therapeutics, psychostimulants, quinidines,radiopharmaceuticals, respiratory stimulants, salt substitutes,scabicides, sclerosing agents, sedatives. sympatholytics,sympathomimetics, thrombolytics, thyroid preparations, tranquilizers,tuberculosis preparations, uricosuric agents, urinary acidifiers,urinary alkalinizing agents, urinary tract analgesic, urologicalirrigants, uterine contractants, vaginal therapeutics and vitamins andeach specific compound or composition listed under each of the foregoingcategories in the PDR®. Some other medicaments that can be used withinjector device 100 include Ergocalciferol (Calciferol),diethylstilbestrol, Diprovan (propofol), estradiol valerate,fluphenazine decanoate, fulvestrant, intralipid, liposyn, nandrolonedecanoate, nebido, nutralipid, paclitaxel, progesterone, prograf,testosterone cypionate, zuclopenthixol, and haloperidol dodecanoate. Incertain embodiments, the medicament is dissolved in soybean oil, ethyloleate, castor oil, sesame oil, safflower oil, arachis oil,polyoxyyethylated castor oil (Cremophor® EL), polyoxyl 60 hydrogenatedcastor oil (HCO-60), cottonseed oil, or thin oil derived from coconutoil.

In some embodiments, the medicament may be a hazardous agent. “HazardousAgent(s)” as used herein means any one or more medications that aretoxic agents, cytotoxic agents and/or other dangerous agents that maycause serious effects upon contact with a subject as well as highlypotent agents, agents that have profound physiological effects at lowdoses. Exemplary hazardous agents include, without limitation,analgesics, immunomodulating agents, IL-1 receptor antagonists, IL-2alpha receptor antagonists, anti-rejection compounds, hormonal agents,prostaglandins, sedatives, anticholinergic agents, Parkinsons diseasedrugs, expensive agents, neuroleptic agents, tissue necrosis factor(TNF) blockers, and other dangerous agents. Examples of hazardous agentssuitable for use with injection device 100 in accordance with thepresent invention include, but are not limited to, those disclosed inU.S. Patent Application Publication No. 2012/0157965 entitled “HazardousAgent Injection System” (to Paul Wotton et. al, published Jun. 21,2012), which is incorporated by reference herein in its entirety.Particular examples of cytotoxic agents include, without limitation,6-mercaptopurine, 6-thioinosinic acid, azathioprine, chlorambucil,cyclophosphamide, cytophosphane, cytarabine, fluorouracil, melphalan,methotrexate, uramustine, anti-cytokine biologicals, cell receptorantagonists, cell receptor analogues, and derivatives thereof. Examplesof highly potent agents include, without limitation, steroids such asdexamethasone, progesterone, somatostatin, and analogues thereof;biologically active peptides such as teriparatide; and anticholinergicssuch as scopolamine. Examples of agents that have profound physiologicaleffects at low doses include, without limitation, antihypertensivesand/or blood pressure down regulators. Examples of analgesics include,without limitation, fentanyl, fentanyl citrate, morphine, meperidine,and other opioids. Examples of immunomodulating agents include, withoutlimitation, adalimumab (anti-tissue necrosis factor monoclonal antibodyor anti-TNF). Examples of IL-1 receptor antagonists include, withoutlimitation, anakinra. Examples of IL-2 alpha receptor antagonistsinclude, without limitation, daclizumab and basiliximab. Examples ofanti-rejection compounds include, without limitation, azathioprine,cyclosporine, and tacrolimus. Examples of hormonal agents include,without limitation, testosterone, estrogen, growth hormone, insulin,thyroid hormone, follicle stimulating hormone (FSH),epinephrine/adrenaline, progesterone, parathyroid hormone, gonadotrophinreleasing hormone (GHRH), leutinizing hormone releasing hormone (LHRH),other hormones such as those where contact with the hormone by membersof the opposite sex can lead to side effects, and derivatives thereof.Examples of prostaglandins include, without limitation, gamma-linolenicacid, docosahexanoic acid, arachidonic acid and eicosapentaenoic acid.Examples of sedatives include, without limitation, barbiturates such asamobarbital, pentobarbital, secobarbital, and phenobarbitol;benzodiazepines such as clonazepam, diazepam, estazolam, flunitrazepam,lorazepam, midazolam, nitrazepam, oxazepam, triazolam, temazepam,chlordiazepoxide, and alprazolam; herbal sedatives such as ashwagandha,duboisia hopwoodii, prosanthera striatiflora, kava (piper methysticum),mandrake, valerian, and marijuana, non-benzodiazepine sedatives (a.k.a.“Z-drugs”) such as eszopiclone, zaleplon, zolpidem, zopiclone;antihistamines such as diphenhydramine, dimenhydrinate, doxylamine, andpromethazine; and other sedatives such as chloral hydrate. Examples ofanticholinergic agents include, without limitation, dicyclomine,atropine, ipratropium bromide, oxitropium bromide, and tiotropium.Examples of Parkinson's disease drugs include, without limitation,levodopa, dopamine, carbidopa, benserazide, co-ceraldopa, co-beneldopa,tolcapone, entacapone, bromocriptine, pergolide, pramipexole,ropinirole, piribedil, cabergoline, apomorphine, and lisuride. Examplesof expensive agents include, without limitation, human growth hormoneand erythropoietin. Examples of neuroleptic agents includes, withoutlimitation, antipsychotics; butyrophenones such as haloperidol anddroperidol; phenothiazines such as chlorpromazine, fluphenazine,perphenazine, prochlorperazine, thioridazine, trifluoperazine,mesoridazine, periciazine, promazine, triflupromazine, levomepromazine,promethazine, and pimozide; thioxanthenes such as chlorprothixene,clopenthixol, flupenthixol, thiothixene, and zuclopenthixol; atypicalantipsychotics such as clozapine, olanzapine, risperidone, quetiapine,ziprasidone, amisulpride, asenapine, paliperidone, iloperidone,zotepine, and sertindole; and third generation antipsychotics such asaripiprazole and bifeprunox. Examples of TNF blockers includes, withoutlimitation, etanercept.

In some embodiments, the hazardous agent can be selected from botulinumtoxin, injectable gold, 6-mercaptopurine, 6-thioinosinic acid,azathioprine, chlorambucil, cyclophosphamide, cytophosphane, cytarabine,fluorouracil, melphalan, methotrexate, uramustine, anti-cytokinebiologicals, cell receptor antagonists, cell receptor analogues,dexamethasone, progesterone, somatostatin, analogues of dexamethasone,analogues of progesterone, analogues of somatostatin, teriparatide,scopolamine, antihypertensives, blood pressure down regulators,fentanyl, fentanyl citrate, morphine, meperidine, other opioids,adalimumab (anti-tissue necrosis factor monoclonal antibody oranti-TNF), anakinra, daclizumab, basiliximab, azathioprine,cyclosporine, tacrolimus, testosterone, estrogen, growth hormone,insulin, thyroid hormone, follicle stimulating hormone (FSH),epinephrine/adrenaline, gamma-linolenic acid, docosahexanoic acid,arachidonic acid, eicosapentaenoic acid, amobarbital, pentobarbital,secobarbital, phenobarbitol, clonazepam, diazepam, estazolam,flunitrazepam, lorazepam, midazolam, nitrazepam, oxazepam, triazolam,temazepam, chlordiazepoxide, alprazolam, ashwagandha, duboisiahopwoodii, prosanthera striatiflora, kava (piper methysticum), mandrake,valerian, marijuana, eszopiclone, zaleplon, zolpidem, zopiclone,diphenhydramine, dimenhydrinate, doxylamine, promethazine, chloralhydrate, dicyclomine, atropine, ipratropium bromide, oxitropium bromide,tiotropium, levodopa, dopamine, carbidopa, benserazide, co-ceraldopa,co-beneldopa, tolcapone, entacapone, bromocriptine, pergolide,pramipexole, ropinirole, piribedil, cabergoline, apomorphine, lisuride,human growth hormone, erythropoietin, haloperidol, droperidol,chlorpromazine, fluphenazine, perphenazine, prochlorperazine,thioridazine, trifluoperazine, mesoridazine, periciazine, promazine,triflupromazine, levomepromazine, promethazine, pimozide,chlorprothixene, clopenthixol, flupenthixol, thiothixene,zuclopenthixol, clozapine, olanzapine, risperidone, quetiapine,ziprasidone, amisulpride, asenapine, paliperidone, iloperidone,zotepine, sertindole, aripiprazole, bifeprunox, etanercept, derivativesof any of the foregoing, and combinations of any of the foregoing.

While injection device 100 can deliver an injection of up toapproximately 1 mL per injection, other volumes can be injected inalternative embodiments.

According to certain exemplary embodiments, injection device 100 can beconfigured to inject medicament stored within a prefilled syringe.Prefilled syringes that are manufactured by a blown glass process canhave significant dimensional tolerances and unevenness. Accordingly,features of injection device 100 can serve to accommodate the shapeirregularities and to properly position and locate a prefilled syringewithin injection device 100. Further, injection device 100 can beconfigured as a needle-assisted jet injector, providing a peak pressureduring the injection of less than about 1,000 p.s.i., preferably lessthan 500 p.s.i., and more preferably less than about 350 p.s.i. At anend of an injection, the pressure applied to the medicament ispreferably at least about 80 p.s.i., more preferably at least about 90p.s.i., and most preferably at least about 100 p.s.i. In one embodiment,the initial pressure can be around 330 p.s.i., and the final pressurecan be about 180 p.s.i., while in another embodiment the initialpressure can be about 300 p.s.i., dropping to around 1110 p.s.i. at theend of the injection. These exemplary pressures can, for example, resultin a flow rate of about 0.2 mL/sec to 0.75 mL/sec, and preferably about0.5 mL/sec. The needles used are preferably between 26 and 28 gauge, andare most preferably around 27 gauge, but alternatively other needlegauges can be used where the other components are cooperativelyconfigured to produce the desired injection. In preferred jet injectorembodiments firing aqueous medicaments, the firing mechanism, medicamentcontainer, needle, and energy source are configured to produce anaverage stream velocity within the needle of at least about 1,000cm/sec, and more preferably at least about 1,500 cm/sec, up to about5,000 cm/sec, and more preferable up to about 3,000 cm/sec. In oneembodiment, the average stream velocity during injection is about orreaches between about 1,800 and 2,200 cm/sec or approximately 2,000cm/sec. The velocities used to produce a jet injection will vary forother types of medicaments, such as based on their viscosities. Weakerenergy sources, and/or larger needles, for example, can be used toobtain lower velocities and lower pressures and/or flow rates fortraditional, low-pressure autoinjector embodiments. Such embodiments canalso benefit from the axial rotation between the trigger engagementmember and the retainer portion, while moving from the pre-firingcondition to the firing condition upon a proximal movement of theskin-contacting member with respect to housing.

As shown in FIG. 1B, the exemplary injection device 100 can include anouter housing 102, a cap 104, and a housing end/end cap 106. Injectiondevice 100 can further include various components and/or assemblieshoused within outer housing 102. As shown in FIG. 1B, these componentscan include a guard 108, a container support, such as, e.g., a sleeve110, a firing mechanism 112, a medicament chamber 114, a needle 116, anda spring 118. As shown in FIG. 1A, outer housing 102 can be a singlepiece component, or alternatively, outer housing 102 multiple pieceassembly that can be coupled together, for example, via a snap-fitconnection, a press-fit connection, a threaded engagement, adhesives,welding, or the like.

As shown in FIG. 1B, cap 104 is removably affixable to a distal end ofouter housing 102, and housing end/end cap 106 is coupled to a proximalend of housing 102. For example, cap 104 can be removably affixed to thedistal end of housing 102 via a threaded engagement and housing end 106can include features (e.g., projections) configured to engage a portionof the proximal end of housing 102 (e.g., openings) to couple housingend/end cap 106 to housing 102. When affixed to injection device 100,cap 104 can ensure that an injection is not triggered by an inadvertentapplication of a force to guard 108. Preferably, cap 104 includes twoengagement features. As shown in FIG. 14, cap 104 can include engagementfeatures 1040 and 1042. Engagement features 1040 and 1042 can be threadsconfigured to threadedly engage other features of injection device 100.For example, engagement feature 1040 can be configured secure cap 104 tothe distal end of housing 102 (e.g., via a threaded engagement with adistal portion of sleeve 110), and engagement feature 1042 can beconfigured to threadedly engage features of guard 108 to preventproximal displacement of guard 108. For example, FIG. 1B shows feature1042 engaged with feature 1080 a of guard 108, thereby preventingproximal movement of guard 108, such as may occur if the injector isaccidentally dropped or otherwise jolted.

Additionally, cap 104 is preferably non-circular in cross-section viewedalong its axis and in the initial, closed position aligns with orsubstantially matches the shape of the portion of the housing adjacentthereto. Features 1040 can include a plurality of threads, having morethan one thread starting point, only one of which will result in the caplining up with the housing as in the initial closed position.Consequently, if the cap is removed and replaced, there is a chance thatan incorrect starting point will be selected by the user, resulting inthe cap no longer aligning with the injector housing, and providing anindication of tampering. In one embodiment, three threads are used, sothere is a two in three chance that a removed and replaced cap willbecome immediately obvious based on an ill-fitting cap.

As shown in FIG. 1C, housing 102 can include openings 1024 configured toengage with sleeve 110 to couple and secure sleeve 110 to housing 102and can include at least one window 1020 that can provide a visualindication of whether or not injection device 100 has been fired. Forexample, in an unfired state, window 1020 can allow a user to seemedicament chamber 114, along with the stored medicament, and in a firedstate, window 1020 can show one or more internal components, such as aportion of firing mechanism 112, which can be a color specificallyselected to alert the user that injection device 100 has been fired, andis preferably sufficiently different than other colors visible to a user(preferably having ordinary eyesight) on the injector prior to firing,so as to be conspicuously different to, or contrast from, any othercolors present or significantly present. For example, the color candiffer from all the other components of injection device 100 pre-firing,or visible by the user pre-firing, so as to be conspicuous (e.g.,introducing an entirely new color family). The new color appearing afterfiring, can be from a non-analogous part of the color wheel, or cancontrast, or can be a complementary color, with respect to the colorsvisible on injection device 100. The new color can signify caution, suchas red or orange, etc. In one embodiment, the colors visible on theinjector in the pre-firing condition, preferably including when the cap104 is on and/or off the injector, are grays and blues, for instance.When the injector is fired, the color red can be introduced. Preferably,this new color can be introduced after firing but prior to guard 108being locked-out in the extended position.

A proximal end of housing 102 can also include a trigger member, whichcan include a trigger member retaining portion 1022. For example,trigger member retaining portion 1022 can include an opening configuredto receive and engage at least a trigger engagement member of firingmechanism 112 (e.g., projections) in facilitating firing of injectiondevice 100. Opening 1022 is preferably configured to engage a triggerengagement member, e.g., projections 1134 of firing mechanism 112, forexample latch tabs, such that they are aligned in one of two positions.For example, in first position 1022 a (e.g., retaining position), theopening can include retaining portions so that projections 1134 offiring mechanism 112 are aligned so that they can be restrained bylateral sides of opening 1022, thereby preventing firing mechanism 112from firing (e.g., by preventing projections 1134 from splaying openfiring mechanism 112 is prevented from slidably displacing under a forceexerted by an energy source) and dispensing the medicament. In secondposition 1022 b (e.g., firing position), the opening can include firingportions such that the projections of firing mechanism 112 are alignedsuch that projections can splay apart, thereby permitting firingmechanism 112 to fire. FIG. 2A shows projections 1134 aligned in thefirst position (1022 a) and FIG. 2B shows projections 1134 aligned inthe second position (1022 b). Further, the lateral walls of theretaining portions of the opening (e.g., in the first position 1022 a)are preferably curved to facilitate rotation of projections 1134 betweenthe first and second positions.

Injection device 100 also preferably includes housing end/end cap 106.As shown in FIG. 3, housing end/end cap 106 preferably includes a bodyportion 1060 and a ram holding member 1062. Ram holding member 1062 canbe a projection, and can be configured to engage a trigger engagementmember of firing mechanism 112. For example, ram holding member 1062 canbe a bell-shaped projection, and can engage a complementary shapedfeature (e.g., projections) of firing mechanism 112. In an exemplaryembodiment, ram holding member 1062 can include a groove 1062 a and abulge 1062 b, and features of firing mechanism 112 can be configured toalign with groove 1062 a so as to hold bulge 1062 b to prevent firing ofinjection device 100. Preferably, ram holding member 1062 and thefeatures of firing mechanism 112 engaging with ram holding member 1062include a circular cross section to allow rotation of the features offiring mechanism 112 relative to ram holding member 1062 during firingof injection device 100. Further, body portion 1060 can includeprojections 1060 a configured to engage openings in outer housing 102 tocouple housing end/end cap 106 to housing 102. In an exemplaryembodiment.

As shown in FIG. 1B, sleeve 110 is preferably at least partially housedwithin outer housing 102 and mounted to outer housing 102 via, forexample, a snap-fit connection, a press-fit connection, a threadedengagement, adhesives, welding, or the like. As shown in FIGS. 4A and4B, for example, sleeve 110 can include projections 1108 configured toengage openings 1024 of housing 102. Sleeve 110 is configured to hold amedicament chamber 114, which can include a needle 116 at a distal endof medicament chamber 114. In certain exemplary embodiments, medicamentchamber 114 can include, for example, a separate glass ampule and aneedle, or a pre-filled syringe, or sleeve 110 itself can include anintegral medicament chamber. Preferably, a plunger 1140 is provided inthe medicament chamber 114. Plunger 1140 is in association with a ram1132 of firing mechanism 112. During an injection, ram 1132 is urged byan energy source of firing mechanism 112 to displace plunger 1140distal, deeper into medicament chamber 114, dispensing the medicamentthrough needle 116. Needle 116 can include an injecting tip 1160 thatcan be configured to penetrate the skin of a user and a hollow bore thatis in fluid communication with medicament chamber 114 to facilitatedelivery of medicament from medicament chamber 114 to a user during aninjection. FIGS. 1A and 1B show injection device 100 in a pre-firingstate, with cap 104 secured to outer housing 102 and injection device100 in a pre-firing position. The operation of injection device 100,including its various stages and positions, are described in furtherdetail below.

As shown in FIGS. 4A and 4B, sleeve 110 can include a ring-likestructure 1100, a coupling arrangement 1102, and a body portion 1104.Coupling arrangement 1102 can be disposed at a distal portion of sleeve110 and can be configured to releasably engage cap 104. For example,coupling arrangement 1102 can include threads configured to providethreaded engagement between sleeve 110 and cap 104. Further, sleeve 110can include a body portion 1104 configured to secure medicament chamber114. Body portion 1104 can include guides, such as grooves 1104 a,configured to engage with features of guard 108 to align and guide axialdisplacement of guard 108. A proximal end of sleeve 110 can include amedicament chamber support 1106 configured to support and secure aproximal portion of medicament chamber 114. For example, support 1106can be configured as a syringe support configured to hold a proximal endof syringe (e.g., finger flanges of a prefilled syringe) and can supportmedicament chamber 114 during the forces exerted on it during firing.Further, support 1106 can include an elastomer or a rubber, and can beconfigured to at least partially absorb the shock or a force exerted onmedicament chamber 114 during an injection. Additionally, sleeve 110 caninclude various features, such as projections 1108, configured to couplesleeve 110 to outer housing 102. For example, projections 1108 can toconcentrically symmetrical and configured to engage openings 1024 inouter housing 102 to secure sleeve 110 to outer housing 102. In anexemplary embodiment, projections 1108 can be disposed on legs 1110,which can be concentrically symmetrical and configured to engage withfeatures of guard 108. Additionally, sleeve 110 can include lockingfeatures, such as locking projections 1112, disposed on legs 1114, whichcan be concentrically symmetrical, and can be configured to engagefiring mechanism 112 in locking out injection device 100 to prevent auser from attempting to use an already-fired injection device 100.

Ring-like structure 1100 can include several features configured toengage sleeve 110 with glass medicament chamber 114, firing mechanism112, and guard 108. For example, ring-like structure 1100 can include anopening 1116 through which needle 116 can be received. Further,ring-like structure 1100 can include concentrically symmetrical openings1118 which can be configured to receive legs of guard 108. Additionally,ring-like structure 1100 can be configured to support a distal portionof medicament chamber 114 and engage firing mechanism 112 in preventingfurther axial displacement of firing mechanism 112 during dispensing ofthe medicament. Operation of these components are described in furtherdetail below.

As shown in FIGS. 5A and 5B, injection device 100 preferably includes aguard 108 slidably mounted at least partially within outer housing 102and configured to engage firing mechanism 112 to actuate firing ofinjection device 100. Preferably, guard 108 is slidably movable relativeto outer housing 102 between an extended (e.g., a distal, protective)position and a retracted (e.g., proximal) position. In the extendedposition, guard 108 preferably covers needle 116, and in the retractedposition, needle 116 is not covered by guard 108 and is thereby exposed.For example, FIG. 9A shows guard 108 in the extended position, and FIG.10A shows guard 108 in the retracted position. Preferably, guard 108 isresiliently biased toward the extended position via a spring 118, whichcan be disposed, for example, between a distal surface of ring-likestructure 1100 of sleeve 110 and an interior surface of a distal end ofguard 108.

In an exemplary embodiment, guard 108 includes a distal portion 1080 andlegs 1082. In an exemplary embodiment, the distal end of guard 108preferably includes a skin-contacting member. Distal portion 1080includes an opening through which needle 116 can pass and projections1080 a. Projections 1080 a can be configured to about a distal edge ofsleeve 110 so as to limit the proximal displacement of guard 108. Forexample, as guard 108 is proximally displaced under a force applied by auser during an injection, projections 1080 a will come into contact withthe proximal edge of sleeve 110 so that guard 108 cannot be furtherproximally displaced. Further, projection 1080 a can be configured toengage engagement feature 1042 of cap 104 so that guard 108 cannot beproximally displaced when engaged with engagement feature 1042 of cap104.

Legs 1082 of guard 108 are preferably configured to be received inopenings 1118 of ring-like structure 1100. Further, legs 1082 caninclude ridges 1082 a configured to engage grooves 1104 a of sleeve 110,to facilitate alignment and guiding of legs 1082 as guard 108 is axiallydisplaced. As shown in the exemplary embodiments of FIGS. 5A and 5B,legs 1082 also preferably include firing-initiation members, such ascamming surfaces 1084 at a proximal end of legs 1082. In an exemplaryembodiment, legs 1082 and camming surface 1084 can be concentricallysymmetrical. Camming surfaces 1084 are configured to engage firingmechanism 112 in initiating a firing of injection device 100 andperforming an injection of the medicament stored in medicament chamber114. The proximal ends of legs 1082 can also be sloped to facilitatelegs 1082 being received within firing mechanism 112 when guard 108 isdisplaced from the extended position to the retracted position.Preferably, legs 1082 include projections 1086 disposed on springs 1088which can also include sloped surfaces 1088 a. Projections 1086 can beconfigured to engage proximal surfaces of legs 1110 of sleeve 110 tooppose a force exerted by spring 118, which biases guard 108 in theextended position. Further, sloped surfaces 1088 a can be configured toengage an interior surface of legs 1110 of sleeve 110 so that as guard108 is displaced from the extended position to the retracted position,sloped surfaces 1088 a engage the interior surfaces of legs 1110 so asto bias springs 1088 towards an interior of injection device 100.

As shown in FIG. 1B, injection device 100 also preferably includesfiring mechanism 112. Firing mechanism 112 can include a ram assembly1120 slidably mounted within housing 102 and an energy source 1122. Inan exemplary embodiment, the energy source 1122 preferably includes acompression spring 1122, however, other suitable energy source can beused, such as an elastomer or compressed-gas spring, or a gas generator,or other suitable energy storage members. In FIG. 1A, ram assembly 1120is in a pre-firing proximal-most position. During an injection, ramassembly 1120 is urged distally by energy released by energy source1122. Once an injection is completed, firing ram assembly 1120 isdisposed in a distal position (as shown in FIG. 12B). In this distalposition, guard 108 is locked-out so that a user cannot attempt asubsequent injection. Although shown as a single piece, ram assembly1120 can be a multiple piece assembly that can be coupled together, forexample, via a snap-fit connection, a press-fit connection, a threadedengagement, adhesives, welding, or other suitable couplings. Ramassembly 1120 preferable includes various features that can beconfigured to facilitate firing of injection device 100 to dispense themedicament stored in medicament chamber 114. According to certainexemplary embodiments of the present disclosure, a trigger mechanism ofinjection device 100 can include ram assembly 1120, the trigger memberand trigger retaining portion 1022, and ram retaining holding member1060.

As shown in FIGS. 6A and 6B, in an exemplary embodiment, ram assembly1120 can include a distal portion 1124 and a proximal portion 1126separated by a feature 1138, such as a lip, a ledge, that can beconfigured to act as a seat for energy source 1122. In an exemplaryembodiment, compression spring 1122 can be disposed between a proximalend of housing 102 and feature 1138. Distal portion 1124 can besubstantially cylindrical and can be configured to concentricallyreceive at least a portion of sleeve 110 and guard 108. Distal portion1124 can also include openings 1128 configured to receive legs 1110 ofsleeve 110 and projection 1086 of guard 108. An interior surface ofdistal portion 1124 can include camming surfaces 1124 a configured toengage camming surfaces 1084 of guard 108. FIG. 16 shows engagement ofcamming surfaces 1124 a with camming surfaces 1084 of guard 108 in apre-fired state. As guard 108 is moved in the direction A during aninjection, the axial movement of guard 108 is translated into arotational movement of ram assembly 1120 via the engagement of cammingsurfaces 1124 a and 1084.

Proximal portion 1126 preferably includes legs 1130, a ram 1132, and atrigger engagement member, such as, e.g., projections 1134. Although thetrigger engagement member is shown as projections 1134, alternativeimplementations are contemplated. The trigger engagement member caninclude any feature (e.g., an elongated tab, a recess, a protrusion, abulge, a thread, etc.) that can be held by ram retaining member in thepre-firing state, and released upon rotation of the trigger engagementmember. For example, the ram retaining member can be shaped such that itprevents axial movement of the trigger engagement member in a firstposition, but releases trigger engagement member in a rotationallytranslated second position. Camming surfaces 1124 a and 1084 arepreferably oriented at an angle with respect to the longitudinal axis ofthe device to achieve a selected force and throw required to depress theguard 108 from the extended to the retracted position to fire thedevice. In some embodiments, the camming surfaces are angled at between15° and 75° with respect to the axis, and more preferably between about20° and 45°. In one embodiment, the camming surfaces are angles at about30° with respect to the axis.

As shown in FIGS. 6A and 6B, legs 1130 include openings 1136 configuredto engage locking projections 1112 of sleeve 110. For example, lockingprojections 1112 of sleeve 110 can engage openings 1136 of firingmechanism 112 after injection device 100 has been fired, locking-outinjection device 100 so that a user cannot initiate another firing ofinjection device 100. Ram 1132 is configured to be in association withplunger 1140, and distally displace plunger 1140 under the force ofenergy source 1122 to dispense the medicament contained in medicamentchamber 114 during an injection. Additionally, projections 1134 can bedisposed at a proximal end of proximal portion 1126 and can beconfigured to engage opening 1022 of housing 102 and ram holding member1062 of housing end/end cap 106. The engagement of projections 1134 withopening 1022 and ram holding member 1062, as well as the alignment ofprojections 1134 within opening 1022 can control and enable firing ofinjection device 100. For example, projections 1134 can include bulges1134 a configured to engage groove 1062 a of ram holding member 1062,and shapes 1134 b configured to engage bulge 1062 b of ram holdingmember 1062. As noted above, projections 1134 and ram holding member1062 preferably include circular cross-sections to allow rotation of ramassembly 1120 during firing of injection device 100. FIG. 15 shows acloseup view of the engagement of trigger engagement member (e.g.,projections 1134) with ram holding member 1062.

In certain embodiments, the engagement of the ram holding member 1062 ofhousing end/end cap 106 with projections 1134 of ram assembly 1120creates a latch retention angle 1500. In one embodiment, latch retentionangle 1500 is defined by axis 1502 and the contact surface of a distalportion of groove 1062 a of ram holding member 1062 of housing end/endcap 106 and bulge 1134 a of projections 1134 of ram assembly 1120. Incertain embodiments, projections 1134 and ram holding member 1062 aresized and shaped to create, when engaged, a latch retention angle 1502of about 10°, about 11°, about 12°, about 13°, about 14°, about 15°,about 16°, about 17°, about 18°, about 19°, about 20°, about 21°, about22°, about 23°, about 24°, about 25°, about 26°, about 27°, about 28°,about 29°, about 30°, about 31°, about 32°. about 33°, about 34°, about35°, about 36°, about 37°, about 38°, about 39°, about 40°, about 41°,about 42°, about 43°, about 44°, about 45°, about 46°, about 47°, about48°, about 49°, about 50°, about 51°, about 52°, about 53°, about 54°,about 55°, about 56°, about 57°, about 58°, about 59°, about 60°, about61°, about 62°, about 63°, about 64°, about 65°, about 66°, about 67°,about 68°, about 69°, about 70°, about 71°, about 72°, about 73°, about74°, about 75°, about 76°, about 77°, about 78°, about 79°, about 80°,about 81°, about 82°, about 83°, about 84°, about 85°, about 86°, about87°, about 88°, about 89° or any range determinable from the precedingangles (for example, about 39° to about 41° or about 79° to about 81°).

FIGS. 8A-12B show the various stages and states of exemplary injectiondevice 100. FIGS. 8A and 8B show injection device 100 in a pre-firing“safeties-on” configuration. For example, in the pre-firing“safeties-on” configuration, injection device 100 is in a pre-firingstate and cap 104 is affixed to injection device 100. In thisconfiguration, guard 108 is in the extended position under force ofspring 118 covering needle 116, ram assembly 1120 is in its proximalposition, and energy source 1122 has not released its energy. Further,in this state, projections 1134 of ram assembly 1120 are engaged withopening 1022 and aligned in the first position 1022 a (e.g., pre-firingcondition) of opening 1022. Further, projection 1134 are also engagedwith ram holding member 1062 of housing end/end cap 106. In thisposition, the engagement of projections 1134 with ram holding member1062 of housing end/end cap 106 oppose the force of energy source 1122.Further, with projections 1134 aligned within the first position 1022 aof opening 1022, the lateral sides of opening 1022 (formed by theproximal end of housing 102) prevent projections 1134 from splaying openand disengaging ram holding member 1062 under the force of energy source1122.

In FIGS. 9A and 9B, injection device 100 is shown in a pre-firing“ready-to-use” state. FIG. 13A shows many of the internal components ofinjection device 100 in this pre-firing “ready-to-use” state withoutshowing housing 102. For example, safety member 104 has been removed,but the user has not otherwise initiated an injection. Accordingly, inthis state, the medicament is still in medicament chamber 114, guard 108remains in an extended position covering needle 116, energy source 1122has not released the energy that its has stored, and projections 1134 ofram assembly 1120 remains engaged with ram holding member 1062 andaligned in the first position (1022 a) of opening 1022.

FIGS. 10A and 10B show injection device 100 in a triggered or“just-used” state. FIG. 13B shows many of the internal components ofinjection device 100 in this triggered or “just-used” state withoutshowing housing 102. In this state, guard 108 has been proximallyslidably displaced (e.g., by application of a force on the distal end ofguard 108) from the extended position to the retracted position, therebyexposing needle 116. Energy source 1122 is just beginning to release itsstored energy (e.g., the exemplary compression spring remainscompressed), and ram assembly 1120 remains in the proximal-mostposition. Injection device 100 may be in this state, for example, duringan initial stage of use by a user. For example, this can be observedwhen the user has pressed guard 108 of injection device 100 against aninjection site to perform an injection. Accordingly, the force exertedby the user in pressing guard 108 of injection device 100 against theinjection site may have proximally displaced guard 108 against the forceof spring 118, thereby displacing guard 108 into the retracted positionand exposing needle 116 to penetrate the user's skin at the injectionsite.

In this triggered state shown in FIG. 10B, guard 108 has been displacedinto the retracted position, camming surfaces 1084 of guard 108 engagecamming surfaces 1024 a disposed on the interior of ram assembly 1120,thereby camming ram assembly 1120 (see FIG. 16). This camming actionrotates ram assembly 1120, causing projections 1134 to become unalignedwith the first position of opening 1022 and become aligned with thesecond position of opening 1022. In this position, projections 1134 areno longer restrained from splaying open by the lateral walls of opening1022. Accordingly, projections 1134 splay open under the force of,energy source 1122, causing projections 1134 to disengage with ramholding member 1062 of housing end/end cap 106. The disengagement ofprojections 1134 with ram holding member 1062 allows ram assembly 1120to be distally slidably displaced relative to housing 102 under theforce generated by energy source 1122. The distal displacement of ramassembly 1120 is preferably restrained by ram assembly 1120 abutting aproximal surface of ring-like structure 1100 of sleeve 110.

FIGS. 11A and 11B show injection device 100 in a “just-injected” state.This state follows the disengagement of projections 1134 with ramholding member 1062 and the distal displacement of ram assembly 1120described above. In this state, energy source 1122 (e.g., a compressionspring) has released its energy, thereby distally displacing ramassembly 1120. Further, guard 108 remains compressed in the retractedposition. This state may be observed during use of injection device 100immediately following the state shown in FIGS. 10A and 10B. As describedabove, camming of ram assembly 1120 aligns projections 1134 with thesecond position defined by opening 1022, allowing projections 1134 tosplay open and disengage ram holding member 1062 under the forcereleased by energy source 1122. Accordingly, energy source 1122 hasreleased at least some, if not all, of its stored energy (e.g.,compression spring is less compressed), and ram assembly 1120, as wellas ram 1132, has been distally displaced into a distal position. Thedistal displacement of ram 1132 urges plunger 1140 in a distaldirection, injecting the medicament into the user by dispensing themedicament in medicament chamber 114 through needle 116 and into theuser. Although the injection has preferably been completed in thisstate, injection device 100 is still likely pressed against theinjection site since guard 108 remains in a retracted position exposingneedle 116. Further, this distal displacement of ram assembly 1120preferably positions ram assembly 1120 such that it is displayed inwindow 1020 of housing 102. In an exemplary embodiment, after the distaldisplacement of ram assembly 1120, it is disposed between medicamentcontainer 114 and housing 102 such that it is entirely occluding window1020 so that only ram assembly 1120 is visible through window 1020, andmedicament container 114 is no longer visible (e.g., ram assembly isdisposed between medicament container 114 and window 1020). Further, ramassembly 1120 can have a color (as described above) that would be aclear indicator to a user that injection device 1.00 has been used, anddifferent than the other colors visible from the outside of the injectorbefore firing.

FIGS. 12A and 12B show injection device 100 in a “locked-out” state.FIG. 13C shows many of the internal components of injection device 100in this “locked-out” state without housing 102. The state can beobserved, for example, after the user has removed injection device 100from the injection site. In this state, nothing is restraining guard 108in the retracted position against the force of spring, and accordingly,guard 108 is distally displaced from the retracted position to theextended position under the force of spring 118, thereby covering needle116. As guard 108 moves distally from the retracted position to theextended position under the force of spring 118, projections 1086, whichare disposed on springs 1088 biased in an outward direction, engage anopenings created between proximal surfaces of legs 1110 of sleeve 110and proximal walls of openings 1128. Accordingly, the association ofprojections 1086 with the proximal walls of openings 1128 prevents guard108 from being displaced proximally, and the association of projections1086 with the proximal surfaces of legs 1110 prevents guard 108 frombeing displaced distally. Thus, guard 108 is in a locked position,thereby “locking-out” injection device 100 such that needle 116 iscovered and guard 108 is locked in place so that a user cannot attempt asubsequent injection. Afterwards, the user may affix cap 104 back ontothe distal end of injection device 100.

Advantageously, this “locked-out” state is preferably not dependent ondisplacement of guard 108, but rather, is preferably dependent ondispensing of the medicament stored in medicament chamber 114 and/ormovement of ram assembly 1120. For example, injection device 100 becomelocked-out in situations where the medicament is inadvertentlydispensed, even if guard 108 has not been displaced. Injection device100 can become locked-out in any instance where energy source 1122 isactivated and ram assembly 1120 is distally displaced, causing ram 1132to displace plunger 1140, thereby dispensing the medicament inmedicament chamber 114. This can occur, for example, if injection device100 is mishandled, dropped, broken, or if housing 102 is defective(e.g., the tolerances of opening 1022 are incorrect, housing 102 iscracked or otherwise compromised, etc.) such that the lateral walls ofopening 1022 cannot prevent projections 1134 from splaying outward underthe force of energy source 1122. Accordingly, the lock-out featureprevents a user from unknowingly performing an “injection” with an emptyinjection device 100, even if injection device 100 appears to be new andnot used. This can be important in preventing patients from believingthat they have administered an injection when in fact the injector wasempty.

In an exemplary embodiment, many of the components of injection device100 are preferably made of a resilient plastic or polymer, or a metal.Preferably, projections 1134 of ram assembly 1120 are oriented so thatram assembly 1120 can be molded using a single mold. For example, asshown in FIGS. 6B and 13C, projections 1134 (which are preferablyconcentrically symmetrical to each other) can be aligned at an anglerelative to the alignment of the other features of ram assembly 1120,such as legs 1130 (which are preferably concentrically symmetrical toeach other). For example, as shown in FIG. 17, a single mold can formthe portion of ram assembly 1120 designated A (including all thefeatures, components, openings, etc. 1130A), and a single mold can formthe portion of ram assembly designated B (including all the features,components, openings, etc. 1130B). Thus, each surface of projections1134 is preferably accessible along a direction of separating the twomolds, and the two molds can be separated linearly without a concaveportion of projections 1134 facing orthogonal to the separationdirection impeding separation and removal of the molds.

Further, cap 104 can be configured helically so that it can be moldedwithout a hole/opening. For example, cap 104 can include threads 1044that permit cap 104 to be threadedly removed from a mold. Further, outerhousing 102 can include a translucent material to allow users to viewthe inner workings of injection device 100, and ascertain if it ismalfunctioning (e.g., as shown in FIGS. 1A, 7, 8A, 9A, 10A, 11A, 12A,and 16). Additionally, injection device 100 can include various grippingelements, such as ridges, pads, contours, or the like, to make injectiondevice 100 more ergonomic, easy to use, and comfortable to the user.Further, injection device 100 can include markings, such as a sticker,brand markings, drug information, numerals, arrows, or the like, toindicate the steps needed to perform an injection, and areas forpromotional markings such as brand and logo designations.

FIG. 18 shows another exemplary embodiment of injection device. As shownin FIG. 18, ram assembly 1120 can include trigger engagement member thattakes the form of a seat or ledge 1120 b. Seat 1120 b can engage aretaining portion, such as ldges 102 a, of housing 102 in the pre-firedcondition such that the engagement of ledges 102 a with the seat 1120 bin the pre-fired condition opposes the force of energy source 1122. Whena firing of injection device 100 is initiated, ram assembly 1120 can berotated, for example, via a camming association of guard 108 and ramassembly (such as described with respect to exemplary embodiments above)until recesses 1120° between the seats 1120 b align with projections 102a in the firing condition. In the firing condition, the force of energysource 1122 is no longer opposed, allowing ram assembly 1120 to bedistally displaced and dispensing the medicament in performing aninjection.

All of the references specifically identified in the detaileddescription section of the present application are expresslyincorporated herein in their entirety by reference thereto. The term“about,” as used herein, should generally be understood to refer to boththe corresponding number and a range of numbers. Moreover, all numericalranges herein should be understood to include each whole integer withinthe range.

While illustrative embodiments of the invention are disclosed herein, itwill be appreciated that numerous modifications and other embodimentsmay be devised by those skilled in the art. For example, the featuresfor the various embodiments can be used in other embodiments. In analternative embodiment, the hosing can be fixed to the bracket, and theinner portion, defining at least the bottom of the chutes can slide inand out of the housing. Other embodiments can include differentmechanisms to cause the rotation of the ram assembly to release it fromthe retainer portion, such as by direct rotation of the ram by a user,such as via a slide or other element accessible on the outside of thehousing, or by a button that is pushed with a finger, or anothertransmission mechanism to rotate the ram or ram assembly. Therefore, itwill be understood that the appended claims are intended to cover allsuch modifications and embodiments that come within the spirit and scopeof the present invention.

1. An injector, comprising: a trigger mechanism including: a triggermember having a retainer portion, and a ram assembly having a ramconfigured to pressurize a medicament container for expelling amedicament therefrom, the ram assembly further having a triggerengagement member configured to engage the retainer portion of thetrigger member in a pre-firing condition; an energy source associatedwith the ram for powering the ram to expel the medicament; and auser-operable firing-initiation member operable for causing an axialrotation between the trigger engagement member and the retainer portionfrom the pre-firing condition to a firing condition in which the triggerengagement member is released from the retainer portion to allow theenergy source to fire the ram.
 2. The injector of claim 1, furthercomprising an injector housing, wherein the firing initiation memberincludes a skin-contacting member disposed at a distal end of theinjector that is movable proximally with respect to the housing when aforce is applied to the skin-contacting member at the distal end of theinjector, the firing initiation member being associated with the triggermechanism and configured to cause the axial rotation between the triggerengagement member and the retainer portion from the pre-firing conditionto the firing condition upon a proximal movement of the skin-contactingmember with respect to housing.
 3. The injector of claim 2, wherein theskin-contacting member includes a needle guard that is retractable andis configured to expose a needle connected to the medicament containerupon the proximal movement of the skin-contacting member.
 4. Theinjector of claim 3, wherein the needle is in fluid communication withthe medicament container for injecting the medicament expelled therefromduring the firing.
 5. The injector of claim 3, wherein the energy sourceand the needle are configured for jet injecting the medicament throughthe needle.
 6. The injector of claim 5, wherein the energy source isconfigured to pressurize the medicament to between about 90 p.s.i. andabout 500 p.s.i. to jet inject the medicament.
 7. The injector of claim5, wherein the energy source and needle are configured for injecting themedicament at an average velocity of at least about 1,000 cm/sec withinthe needle.
 8. The injector of claim 2, wherein the skin contactingmember comprises a first cam, and the ram assembly comprises a secondcam, the first cam being operatively associated with the second cam forcamming the second cam upon the axial movement to rotate the ramassembly with respect to the retainer portion so as to position the ramassembly in the firing condition.
 9. The injector of claim 1, furthercomprising an injection housing, wherein: the trigger engagement memberand the ram are in fixed association, such that rotation of the triggerengagement member rotates the ram; and the ram assembly is associatedwith the firing-initiation member such that operation of thefiring-initiation member rotates the ram assembly within the housing tothe firing condition.
 10. The injector of claim 9, wherein the triggermechanism comprises a ram holding member that axially retains the ramassembly in a proximal position against action of the energy source inthe pre-firing position, the retainer portion retaining the triggerengagement member engaged and held against firing by the ram holdingmember.
 11. The injector of claim 10, wherein in the firing condition,the ram is disengaged from the retainer portion, and the energy sourceovercomes an engagement between the trigger engagement member and theram holding member.
 12. The injector of claim 1, wherein the ramassembly is of unitary construction.
 13. The injector of claim 10,wherein the ram holding member includes a projection that includes abulge and a groove engaged with the trigger engagement member, and theretainer portion retains the engagement of the trigger engagement memberwith the bulge and groove in the pre-firing condition.
 14. The injectorof claim 1, further comprising a container support that is configuredfor holding the medicament container during injection, and wherein theram assembly is configured to engage the container support to lock-outthe injector after an injection.
 15. The injector of claim 14, whereinproximal movement of the user-operable firing-initiation member isblocked by the ram assembly when the injector is locked-out.
 16. Theinjector of claim 1, wherein a pre-firing color gamut is visible fromthe exterior of the injector in the pre-firing condition, the injectorfurther comprising: a housing including a window; and an indicatorhaving an indicator color that is absent from the pre-firing colorgamut, which color is hidden from view within the housing in thepre-fired condition, wherein in the fired condition, the indicator coloris visible through the window from an exterior of the injector forindicating the fired condition.
 17. The injector of claim 16, whereinthe ram assembly includes the indicator.
 18. The injector of claim 17,wherein the ram assembly entirely occludes the window in the firedcondition.
 19. The injector of claim 1, wherein the medicament comprisestestosterone.
 20. An injector, comprising: a trigger mechanismincluding: a trigger member having a retainer portion, and a ramassembly having a ram configured to pressurize a medicament containerfor expelling a medicament therefrom and at least one first cammingsurface, the ram assembly further having a trigger engagement memberconfigured to engage the retainer portion of the trigger member in apre-firing condition; an energy source associated with the ram forpowering the ram to expel the medicament; and a needle guard including auser-operable firing-initiation member operable having at least onesecond camming surface configured to operatively associate with the atleast one first camming surface so as to cause an axial rotation betweenthe trigger engagement member and the retainer portion from thepre-firing condition to a firing condition in which the triggerengagement member is released from the retainer portion to allow theenergy source to fire the rani.
 21. The injector of claim 20, furthercomprising a container support, and wherein the ram assembly isconfigured to engage the container support to lock-out the injectorafter an injection.